System, method, and device for a medical surgery tray

ABSTRACT

A method for organizing surgical instruments and supplies in an operating room in preparation for surgery using a system having two tray devices where a first tray articulates in relation to a second tray. Each tray includes at least one flat work surface disposed in a first reference plane and at least one recessed compartment comprising a bottom surface disposed parallel to the first reference plane and offset therefrom at a first negative offset distance.

PRIORITY CLAIM

The present application is a continuation of U.S. patent applicationSer. No. 15/367,468, filed Dec. 2, 2016, which claims the benefit under35 USC Section 119(e) of U.S. Provisional Patent Application Ser. No.62/263,022 filed on Dec. 4, 2015 titled “System, Method, and Device fora Medical Surgery Tray” by a common inventor.

FIELD OF THE INVENTION

This invention relates generally to surgical instruments and, morespecifically, to a standardized procedural methodology utilizing traysfor transporting sterile surgical instruments to an operating room andpresenting the instruments in a standardized configuration and order,ready-to-use and appropriate for nearly all types of surgery.

BACKGROUND

Storage and sterilization systems for veterinary and human dental andmedical instruments are known in the art. Many devices include featuresto stack and space. In the art of medical surgical instruments, storagetrays for sterilization and storage of instruments are common. However,such systems have limitations. For example, one type of tray, althoughwell adapted for use in a first surgical procedure, is ill suited for asecond type of surgical procedure. A general instrument kit, commonlyused in many operating room procedures, is not suitably versatile toadapt for use as operating room procedures change, are modified, or arereplaced with new procedures.

The term “general instrument kit” refers to a set of devices commonlyused in surgery and includes ringed instruments such as snaps, clamps,Kellys, Ailises, Babcocks, Kochers, needle holders, sponge sticks andscissors, among other rigid instruments. Prior to use, a generalinstrument kit is sterilized and packaged at a location remote from aparticular surgery suite. Before a specific surgery or procedure, therequisite sterilized instrument kit(s) are sent to a particularoperating room, which is being prepared for that specific procedure. Inthe operating room a back table is lined with sterile drapes. Then,sterile supplies are removed from their outer packaging and placed onthis back table. One surgical nurse does a surgical scrub, puts on asterile gown and gloves and rearranges the multiple sterile suppliesneeded for the given procedure—placing them in an arrangement andorder—not governed by specific instructions, not standardized, butrather based on that person's experience and preference, which isdetermined in part on the nature of the surgical procedure and theanticipated sequence of use, probable outcomes, potentialerror-mitigation efforts, and other criteria.

During this preparation, the ringed instruments are removed from sterilebuckets and unstrung from each of two long-armed “stringers.” Thebuckets include other instruments that are not strung on the stringers,but are, rather, left loose in the bottom of the bucket. Theseinstruments, too, need to be arranged for later use and are placed onthe back table. Once all the supplies and instruments are arranged arequired complete count of all the instruments and supplies is made.

The lack of standardization causes delays in both the initialpreparation of the instruments and, more critically, during surgery,especially when a scrub nurse is commonly relieved during a procedure.The replacement scrub nurse, who did not arrange the instruments, doesnot have implicit knowledge of the location of each instrument orsupply. This is a known limitation to the aforementioned method.

Currently used instrument trays contain grooves or recesses, which aredesigned for specific, individual instruments. While many of these knowntrays include additional mechanisms or features configured to holdspecific individual instruments in a preferred orientation, they are notoptimized to hold a large quantity of varying instruments in an“operation ready” position. Other known trays increase adaptability byproviding removable section dividers combined with fixed sectiondividers. However, this is disadvantageous as the removable dividersmust be accounted for and can be dislodged during use. This adds risk bypotentially becoming lost inside the patient during surgery, or simplydislodged causing one or more instruments to be disrupted while on thetray, thus delaying the surgical process, for example.

One known device in the art is a multipurpose surgical instrument traydisclosed by Smith in U.S. Pat. No. 6,426,041, and issued on 2002 Jul.2. One significant limitation of the Smith device, as illustrated bestin FIG. 3 of Smith, is that both a portion of the ring-end of a surgicalinstrument and the “sharp” end of the same instrument rests above, orstands proud, in relation to a first flat top surface of the tray. Thisenables users to be cut or punctured by the sharp end of the instrument,which is very undesirable. It also leaves the sensitive tips of themedical instruments exposed and subject to damage and degradation, thusrequiring replacement often.

Other known devices and techniques include protective tip coversdesigned to protect the patient and staff from sharps injury with acertain degree of success. However, the success is limited as frequentlythese sharps protective tips must be carefully examined prior to use andthe sharp instrument frequently cuts through the protective tip andwrapper or package. This methodology is limited in that it relies uponvisual inspection by a trained, naked eye, and as such is highlyvariable and prone to human error. Furthermore, presuming all sharp tipsare protected, well-inspected, and delivered to the sterile field, andthen the protected instruments are properly placed on the Mayo standand/or back table, the removed sharps protective tips are not trackedonce they are removed from the instrument. Thus presents a majordisadvantage, as it is known that these discarded protective tips maymanage to find a way into the patient; this presents as a foreign objectwith ensuing poor patient outcomes and resultant adverse legalimplications.

Other known art includes U.S. Pat. No. 7,565,972, issued on 2009 Jul.28, titled “Medical Equipment Tray System” to Steppe. This medicalequipment tray system includes three parts: a platform portion, afoldable liner, and a hand-piece cradle. Another known referenceincludes a “Grooved Angled Tray for Ring-Handled Surgical Instrument,”described in U.S. Pat. No. 7,066,328, issued on 2006 Jun. 72 toPulsifer.

To date there is no known or proven methodology that adequately protectsthe patient and the users from sharps injury, while at the same timesecuring and protecting the surgical instruments themselves from damageand facilitating a faster more accurate accounting of instruments andmaterials at all relevant times of a surgical operation. And, despiteattempts in the art at improving surgical trays, there remains a needfor an improved surgical tray that retains all the general/major/traumainstruments, arranges these instruments in a ready-to-use orientation,allows these instruments to be sterilized ahead of use, delivered to theoperating room sterile, and minimizes set up time. Further, thereremains a need for a system and method that standardizes safe andefficient operating procedures. Use of the disclosed surgical instrumenttray in conjunction with the surgical back table using an imprintedmapped back table drape that provides for specific designated areas forspecific surgical instruments and materials commonly present and usedaddresses this need. Also, there is a need for a standardized tray thatreadily, easily, quickly, economically, and efficiently adapts forvarious uses.

SUMMARY OF THE INVENTION

The present invention contemplates a system and method that uses a one-or two-tiered surgical tray specific to the type of surgical procedurebeing performed, and a standardized back table drape having an imprintedmapped out orientation designating specific locations for a second-tiertray and other surgical materials. The primary tray, which is placed ona Mayo stand, also features a unique tray which is attached bymechanical armature to the primary tray. This allows the unique tray tobe presented, retracted and manipulated in and out of the sterile field.The unique tray is equipped with recessed slotted areas specificallydesigned to hold, transfer, receive and secure all sharps instrumentsbetween the surgical scrub nurse and the surgeon during intraoperativesurgical procedures.

The trays use unique features and elements that make safe and moreefficiently organize instruments. The method improves the safety andefficiency of relaying the instruments during the surgical procedure.The surgical tray of the present invention can be conventionallysterilized and purposefully arranges surgical instruments in aperpendicular fashion in a space and manor similar to that used bysurgical scrub nurses on their conventional Mayo stand and back tables,as well as to hold, and display with easy access, a predetermined numberof surgical instruments in pre-designated locations. This serves to safeguard against commonly occurring sharps injuries to the patient andstaff members of the preoperative setup, intraoperative procedure, andthe post-operative re-sterilization process, in addition to safelysecuring surgical instruments from unnecessary damage and degradationrequiring replacement. Additionally, the trays and back table drape,used in the method of set up contemplated, facilitates faster, moreefficient and accurate accounting of surgical instruments and materialspresent in the operating room.

The tray may be sterile processed and delivered to the operating room ina sterile manner and quickly accessed for use. The design andconstruction of the tray, with recessed sections of defined shapes andsizes, designed to accommodate particular instruments and retractors,enables a user to extract a given instrument from the tray in a “readyposition”, which may then be relayed to the surgeon with no furthermanipulation of the instrument.

The tray of the present invention, accordingly, is delivered to theoperating room in a “ready-to-use” state, with the tray pre-populatedwith instruments. Each instrument is in a predetermined location on thetray, with the tray having features that retain each individualinstrument in a predetermined orientation. This minimizes scrub nurseset up time, increases safety, improves efficiencies, and further helpsto minimize procedural operating room count time between the scrub nurseand the circulating operating room nurse, while safely andsimultaneously protecting the patient and operating room staff fromcommonly occurring sharps injuries during the preoperative,intraoperative and postoperative phases of the surgical procedure aswell as protecting and safeguarding the surgical instruments.

The present invention further reduces preoperative set up time.

Without limitation, one aspect of the claimed invention includes amedical surgery tray for holding at least one medical instrument havinga handle end and a working end. The tray is comprised of at least onesubstantially flat work surface disposed in a first reference plane, anedge feature surrounding the at least one substantially flat worksurface that stands proud at a predetermined first positive offsetdistance from the first reference plane and comprises at least awork-surface-side wall intersecting the at least one substantially flatwork surface at substantially 90-degrees at a top surface coupled to thework-surface-side wall, wherein the top surface disposes generallyparallel to the first reference plane and further defines the firstpositive offset distance measured from the reference plane; and at leastone recessed compartment comprising a bottom surface disposedsubstantially parallel to the first reference plane and offset therefromat a first negative offset distance. The at least one recessedcompartment further comprises a first support truss disposedintermediate to the reference plane and the bottom surface, the firsttruss comprising at least one tool-support notch and a cooperating andcorresponding second support truss comprising at least one sharps-endsupport groove disposed at a negative offset from the reference planeand the groove further configured whereby the instrument inserted in thecooperating tool-support notch and sharps-end groove arranges theworking end of the medical instrument to lie below the first referenceplane.

In one embodiment, the tray further comprises a second recessedcompartment separate from the first recessed compartment, the secondrecessed compartment comprising a circular opening in the work surfaceand having at least one curvilinear sidewall extender therefrom downwardintersecting with a bottom-platform recessed in a negative offset fromthe reference plane whereby the second recess compartment configures toaccept a fluids container.

Another aspect of the claimed invention encompasses a system fororganizing a plurality of surgical instruments and a plurality ofsurgical supplies in a sterile operating room in preparation for aprocedure, operation, or surgery. The system is comprised of a firsttray and a second tray as described in the foregoing aspect, a linkingsupport member adapted to couple to the first tray at a first proximalend of the linking support member and selectively attach to the secondtray device at a second distal end of the linking support member wherebythe linking support member is further configured to enable the secondtray to rotate into and out of a field of sterilization and furtherconfigured to rotatably move from a first position over the first tray;and the linking support member further comprises an intermediate hingedisposed between the distal and proximal ends.

In one embodiment of the system the linking support member comprises aswing-arm bracket configured to couple to the work surface of the firsttray, the swing-arm bracket further comprising a coupling memberconfigured to engage a portion of the sidewall and work surface of thefirst tray, the coupling member further including a sleeve. A first armmember comprising a pin is disposed on a proximal end, the pinconfigured to slideably engage the sleeve and whereby the pin rotates inthe sleeve, the first arm member further comprising a distal end havinga first-hinge end. A second arm member is comprised of a cooperatingsecond-hinge end configured to hingeably engage the first-hinge end anddisposed on a proximal end of the second arm member, a distal end of thesecond arm member includes a post; and the second tray further comprisesa post-receiving hole configured to rotatably receive the post of thesecond arm member, the second tray configured to be supported by theswing-arm in at least one position offset from the tray. At least onework surface defines a given reference plane, at least one recessedcompartment offset at a negative distance from the given reference planeconfigured to selectively hold at least one surgical instrument in aposition whereby the working end is below the given reference plane.

In another embodiment of the system at least one surgical drape has atleast one predefined area printed thereon. The surgical drape isconfigured to cover a back table in the operating room, with thepredefined area indicating the systematic placement of at least onesurgical instrument or supply.

In yet another aspect of the disclosed invention, a method fororganizing a plurality of surgical instruments and a plurality ofsurgical supplies in a sterile operating room in preparation for aprocedure, operation, or surgery, is provided. The method comprisesproviding or selecting the system disclosed herein; placing at least oneinstrument into a specific location in a first tray, conducting apre-operative accounting of instruments by visually inspecting the trayand observing that there is a corresponding instrument in each specificlocation, and recording the results of the pre-operative accounting.

An embodiment of the method of further comprises conducting apost-operative accounting and placing counted instruments in acontamination-container and transferring the container to the sterileprocessing department, sterilizing one or more instruments, andsterilizing at least one of the first or second tray.

In still another aspect of the disclosed invention, a method comprisesproviding a plurality of trays, a first tray according to claim 1, and asecond tray also according to claim 1; placing the upper tray on a Mayostand; coupling the first tray to a second tray by using a swing-armbracket; placing the second tray outside a sterile field by rotating thebracket away from the first tray; placing the first tray and Mayo standin the sterile field; and placing the second tray on a specificallydesignated location on a back table, the back table being covered by adrape having at least one specific location demarked thereon.

The present invention improves over the known art and includes manyadvantages, including, but not limited to:

-   -   (A) Promoting safety of patients and staff during the        intra-operative process. The importance of improved safety        during the intra-operative is defined annually by The Joint        Council on Accreditation of Hospitals (JCAHO) an organization        made up of individuals from the private medical sector to        develop, maintain, and promote standards of quality care in        medical facilities. In November 2015 the JCAHO website cited the        need for universal protocols to increase patient safety. Failure        of Hospitals to meet the JCAHO requirement may have severe        penalties levied against them. According to the World Health        Organization (WHO), patient safety is a fundamental principal of        healthcare. The care-giving process is inherently risky and        adverse events may result from problems in practice, products        and procedures, or systems. Patient safety improvements demand a        complex, system-wide effort that involves performance        improvement, environmental safety, risk management, equipment        safety, safe clinical care, and safe environmental care. WHO        further defines patient safety as: “The prevention of errors and        adverse effects to patients associated with health care.” The        present invention addresses, answers and improves upon many of        the critical issues and the objectives of these national and        international governing and oversight health care organizations    -   (B) The trays of the various preferred embodiments of the        present invention comply with and exceed the 2000 Federal Needle        Stick and Prevention Act currently in effect and are designed        for patient and staff safety to decrease sharp injuries. The        sharp instruments are recessed into the tray so, for example,        the scrub person may move their arm across the entire tray        without a single sharps cut or stab from the sharp instruments.    -   (C) The disclosed trays include one or more lateral slots to        accept individual instruments and to retain each instrument in a        specific slot, which can be predetermined by a procedure or        method of the present invention. Each slot is further recessed        to ensure that the sharp end of the instrument lies below the        working surface plane of the tray. This ensures that the tray        complies with The 2000 Federal Needle stick Safety and        Prevention Act currently in effect, by identifying and improving        the cited “no hands passing of sharps, syringe needles, trocars        etc.”, and allows for intraoperative relay of dangerous sharp        surgical instruments by incorporating the arm and accompanying        sharps carrier of the present invention, thus decreasing the        potential for injury to staff and patients during the relay        process.    -   (D) The system meets and exceeds the 2000 national Occupational        Safety and Health Administration (OSHA) recommendations and        citations currently in effect.    -   (E) The disclosed trays comply with the Association of        Perioperative Registered Nurses, the National Operating Room        Nurses Associations recommendations (AORN), and the Association        of Surgical Technologists (AST) by safely and efficiently        providing a standardized minimum number of instruments to the        Mayo stand for perioperative procedures.    -   (F) The disclosed trays are part of a standardized surgical        system and method used intra-operatively. This eliminates        guesswork in Mayo stand and back table set up.    -   (G) The disclosed trays are positioned to safely and easily        allow a constant running accountability of surgical instruments        presented at all phases of the surgical procedure.    -   (H) The disclosed trays, when used in the standardized method        disclosed herein facilitate and promote the safe ease of        relaying surgical instruments.    -   (I) When used according to a preferred method according to the        present invention, the disclosed trays decrease medical        liability to all parties concerned and incorporate a “no empty        slot design” during the perioperative procedure.    -   (J) The disclosed trays provide a quick view of surgical        instruments in an instant without further manipulation.    -   (K) The disclosed trays each contain a curved recessed perimeter        underneath each tray that is easily adapted and stabilized to        the standard Mayo tray.    -   (L) When used according to a preferred method, the disclosed        trays reduce mental stress to the operating room personnel under        stressful situations by complying with current national        operating room standards of safety, and efficiency by        introducing a standardized minimum number of instruments to the        Mayo stand in less than a few minutes when used for emergency        surgeries, routine surgeries or as a change in the surgical        procedure dictates to sustain life or promote patient outcomes.    -   (M) The system safely decreases intraoperative set up time and        break down time.    -   (N) The trays are designed for specific and pre-designated “free        work space” areas.    -   (O) The disclosed trays incorporate and establish a design to        promote operating room technique as standardized surgical        procedures on an international level.    -   (P) The disclosed trays allow for safety and “ease of hand-off”        to the break or relief person by using a standardized        configuration and by decreasing the amount of displaced sharps        and surgical instruments.    -   (Q) The disclosed trays decrease costs to surgical facilities by        decreasing the number of re-sterilization of instruments not        contaminated by sending only the number of instruments into the        OR that are necessary or required.    -   (R) The disclosed system reduces costs to hospitals and surgical        suites by providing safe, standardized set up methods and        procedures and reduces downtime between surgical procedures.    -   (S) The system allows and promotes faster training of operating        room personnel.    -   (T) The disclosed trays are easily adapted for use by operating        room technicians, licensed nurses, and—in true emergencies—the        surgeons.    -   (U) The disclosed tray, system, and procedures adapt well for        implementation in the Military, including remote field        hospitals.    -   (V) The standardization of surgical set up promotes positive        patient and staff outcomes of each surgical procedure in various        settings including, but not limited to: in-patient hospitals,        out-patient surgical centers, doctor offices, and veterinary        surgical settings.    -   (W) There are standardized trays adapted for most surgical        procedures.    -   (X) The disclosed trays, system and method promote new higher        safety standards according to the International Association of        HealthCare Service Materials Management (IAHCSMM) through        preparation in a standardized fashion to maintain accuracy or        processing of sterilized instruments and trays.    -   (Y) The disclosed trays, system and method meet or exceed        current safety standards and demands as defined by the World        Health Organization (WHO), as well those standards mandated by        local, state and federal government health agencies.    -   (Z) The disclosed trays, in one embodiment, are constructed        using a modular component design comprising a base containment        platform which is designed to rest on a Mayo stand. The interior        section of each tray is divided up into four separate component        sections which are attached, fashioned and joined to the base        unit using attachment locking mechanisms to fasten and hold all        of the components in place. This allows the end-user to exchange        and replace sections of trays as needed without replacing the        entire tray system. The functional design characteristics,        intended use and applications remain the same, providing the        same benefits as all other embodiments of the design and system.

DRAWINGS

FIG. 1 is a top perspective view of a first tray and a second tray and alinking arm therebetween according to another preferred embodiment ofthe present invention.

FIG. 2 is a front perspective view of the tray and arm assembly shown inFIG. 1.

FIG. 3 is an exploded view of the components of the mounting armassembly and attached tray depicted in FIG. 1, including a bracket,mounting arm and mounting arm-attached tray according to one embodimentof the present invention.

FIG. 4 is a top view of a back-table pre-marked drape according to onepreferred embodiment of the present invention.

FIG. 5 is a top view of the back-table drape of FIG. 4 and shows a trayaccording to an embodiment of the present invention along with surgicalsupplies and instruments located on the pre-marked back-table drape.

FIG. 6A is a front view of a second example tray, calling out similarfeatures to those of the example first tray depicted in FIG. 1.

FIG. 6B is a top view of the tray of FIG. 6A.

FIG. 6C is a left-side view of the tray of FIG. 6A.

FIG. 6D is a right-side view of the tray of FIG. 6A.

FIG. 7 is a top view of an example second tray as depicted in FIG. 1.

FIG. 8 is a top perspective view of the tray of FIG. 1, withoutinstruments arranged therein, further illustrating the recessed slots.

FIG. 9 is a top perspective view of another example tray according tothe present invention.

FIG. 10 is an offset top perspective view of a tray according to anotherpreferred embodiment of the present invention.

FIG. 11 is a flowchart depicting a method useable with the system of thepresent invention.

FIG. 12 is an offset frontal view of a container for managing sharpsused with the system and method of the present invention.

FIG. 13 is a perspective view of another example tray according toanother preferred embodiment of the present invention, showing the trayseparated into modular components.

DESCRIPTION OF THE INVENTION

The disclosed trays, systems and methods will become better understoodthrough review of the following detailed description in conjunction withthe figures. The detailed description and figures provide merelyexamples of the various inventions described herein. Those skilled inthe art will understand that the disclosed examples may be varied,modified, and altered without departing from the scope of the inventionsdescribed herein. Many variations are contemplated for differentapplications and design considerations; however, for the sake ofbrevity, each and every contemplated variation is not individuallydescribed in the following detailed description.

Throughout the following detailed description, examples of varioustrays, systems and methods are provided. Related features in theexamples may be identical, similar, or dissimilar in different examples.For the sake of brevity, related features will not be redundantlyexplained in each example. Instead, the use of related feature nameswill cue the reader that the feature with a related feature name may besimilar to the related feature in an example explained previously.Features specific to a given example will be described in thatparticular example. The reader should understand that a given featureneed not be the same or similar to the specific portrayal of a relatedfeature in any given figure or example.

Overview

FIGS. 1 through 10 depict system 10, a surgical tray system designed tohold necessary instruments for surgical procedures. Each respective trayof system 10 is configured to hold, display, present, or otherwisepresent in a ready-to-use orientation all, substantially all, or mostknown or conceivable surgical tools, instruments, or supplies, andparticularly those instruments generally understood to be a part of a“general instrument kit”.

Each respective tray includes one or more features that, alone or incombination, present, display, or otherwise retain one or more surgicalinstruments such that the sharp or puncture or cutting end of theinstrument(s) are held below the tray's work surface. In this way theuser is unable to cut, prick, slice, or otherwise puncture him- orherself on the sharp end of the instrument when that instrument isstored in the tray at a “ready-to-use” perpendicular orientation.

Each tray also holds and displays, for easy access, multiple forceps,knife-handles and retractors, while taking up minimal space on anoperating room back table.

Each respective tray is made of rubber, plastic, or metal material thatis capable of normal sterilization techniques and may either be reusableor disposable. Accordingly, each tray may include features to facilitatesterilization, such as being disposed with holes for flow during thesterilization process.

As mentioned above and visible in FIG. 1, the present invention invarious preferred embodiments contemplates a two-tiered tray design,which enables a standardized set up prior to any desired procedure wheresterilized instruments and supplies are required. The two trays aredesigned and configured for a specific standardized set up incorporatinga number of specific instruments situated in specifically designatedlocations within system 10.

The design of the two trays further enables users such as operating roompersonnel to quickly inventory, count, and account for all instrumentsand materials/supplies used preoperatively, intra-operatively, andpost-operatively. This system of two trays and the method of use thusenables a more accurate and efficient final accounting of all surgicalinstruments and materials. Although most trays are generally universalin use, there are, in various contemplated alternative and preferredembodiments, some unique tray designs having common features that areoptimized for a particular operation, sequence, procedure, and the like.

The precise ordering and location of individual instruments and suppliesis defined in a standards or method and procedure manual. As will bewell-understood by those having ordinary skill in the relevant art,after the final post-operative accounting, the counted instruments areplaced in a contaminated container and transferred to the sterileprocessing department for re-sterilization according to normal hospitalprotocols. The sterile processing department, after separatesterilization of each of the two trays and all of the instruments,packages each tray with specific instruments and supplies in aprescribed manner—namely, each instrument has a specific, individual,location in a given tray.

The sterile processing room, in a controlled and sterile environment,pre-packages specific instruments in specific trays and seals theensemble together for delivery, in a sterile fashion, to the enddestination of use (i.e., the operating room). Because this assembly isdone in the sterile processing department, should any instrument bedropped or damaged, a replacement can be obtained prior to packaging,thus avoiding waste in the surgery suite, and saving time as well.

All surgical instruments and materials are pre-selected from thesurgeon's preference list according to surgical specialty, placed in atransfer cart and delivered from a sterile processing department and/orfrom the sub-sterile room to the operating room.

Once in the operating room, the system of the presentinvention—particularly, the two trays replete with surgical instrumentsand supplies, as applicable, already pre-loaded in specific,pre-designated locations in a given location on either the first orsecond tray, are then opened in a sterile fashion by the scrub nurse orsurgical technician. This eliminates the need for the scrub nurse toorganize and place each instrument on a given tray. Thus, system 10offers significant benefits: in a hectic, busy, urgent or emergencysituation, this invention saves time and ultimately lives. In theordinary course of use, the invention not only saves time, but alsoprovides a greater ability to track, record, inventory, and account forevery item in the surgical suite.

System 10, especially when used in conjunction with method 100 asdescribed herein is for use upon the operating room setting with noadditional set up time and personnel requirements. System 10 (andcorresponding method 100) provides a unique design intended for thepurpose of protecting operating personnel and patients fromall-to-common sharps injuries preoperatively, intra-operatively andpost-operatively.

Such injuries are a major cause of patient and hospital staff injuries,adverse patient outcomes, staff safety and legal liability and damages.System 10 and method 100 purposefully promotes and maximizes patient andstaff personnel safety with unique safety designs that greatly reduce orcompletely eliminate exposure from sharp objects used in surgeries.

System and Devices

With reference to FIGS. 1 and 2, a first preferred embodiment of thepresent invention is depicted. System 10 consists of a first tray 20 anda second tray 30, which are linked together via an articulating linkingmember 50, which is preferably implemented as a hinged swing-arm.

First tray 20 is configured for use as a medical surgery tray, holdingat least one medical instrument 12 having a handle end 14 and a workingend 16. First tray 20 includes at least one substantially flat worksurface 41 that comprises a reference plane. An edge feature 43surrounds the at least one substantially flat work surface 41 wherebyedge feature 43 includes an edge feature top surface 45 standing proudat a predetermined positive offset distance from the reference plane.Edge feature 43 comprises at least a work-surface-side wall 47intersecting the at least one substantially flat work surface 41 atapproximately 90-degrees. Edge feature top surface 45 is coupled to thework-surface-side wall 47, wherein the top surface 45 disposes generallyparallel to work surface 41 and is further defining the positive offsetdistance measured from the reference plane.

First tray 20 further includes at least one recessed compartment 21comprising a bottom surface 23 disposed substantially parallel to worksurface 41 and offset therefrom at a negative offset distance. The atleast one recessed compartment 21 further comprises a first supporttruss 25 disposed intermediate to work surface 41 and bottom surface 23.First support truss 25 includes at least one tool-support notch 27 and acooperating and corresponding second support truss 29 comprising atleast one support groove 291 disposed at a negative offset from worksurface 41. Groove 291 is further configured so the instrument insertedin the cooperating tool-support notch 27 and groove 291 arranges workingend 16 of medical instrument 12 to lie below work surface 41.

The depiction of recessed compartment 21 in FIGS. 1 and 2 is only onepossible implementation and is in no way intended to be limiting.Recessed compartment 21 may be configured in a wide variety of mannersto accommodate the full range of surgical/medical instruments 12 thatare sharps. Such variations will contemplate changing the placement andsize of support truss 25 and 29, as well as the size of tool-supportnotch 27 and support groove 291. Recessed compartment 21 may includemore or fewer support trusses, and may be presented in a variety ofshapes, e.g. polygonal, square, rectangular, triangular, circular,semi-circular, etc., as necessary to accommodate any particular medicalinstrument 12.

As can be seen in FIG. 1, first tray 20 may further include one or moreadditional recessed compartments 21 that are useable for additionalinstruments. For example, first tray 20 includes a second recessedcompartment 211 separate from the first recessed compartment. Secondrecessed compartment 211 includes a circular opening 213 in the worksurface and having at least one curvilinear sidewall 215 extendingtherefrom downward intersecting with a bottom-platform 217 recessed in anegative offset from work surface 41 whereby the second recessedcompartment configures to accept a fluids container, for example.

Second tray 30 is constructed of identical or similar materials to firsttray 20 and varies from first tray 20 primarily in size andconfiguration of the various recessed compartments. Second tray 30includes a corresponding at least one work surface 31 defining areference plane, at least one recessed compartment 34 offset at anegative distance from this reference plane and is configured toselectively hold at least one medical instrument 12 in a positionwhereby working end 16 is below this reference plane.

First tray 20, second tray 30, and other similarly implemented traysuseful with system 10 consist, comprise, or otherwise include, aremanufactured, molded, stamped, or machined of, or from, sturdy plastic,metal, composite, or any other material or combination of materials nowknown or later developed that are coated, painted, rubberized, finished,sealed, or left in a state as a natural result of the process used tocreate the tray, so long as such materials are useful for use in asurgical environment and are sufficiently durable to withstand thestresses imposed by repeated sterilization processes.

Linking member 50 attaches or otherwise couples to first tray 20 at afirst proximal end 51 of the linking support member and selectivelyattaches or otherwise couples to any additional tray, such as secondtray 30, at a second, distal end 53 of the linking support member.Linking member 50 is configured to enable second tray 30 to rotate intoand out of a field of sterilization and is further configured torotatably move from a first position over first tray 20. In the presentembodiment, linking member 50 further includes an intermediate hinge 55disposed between the distal and proximal ends.

Linking member 50 further is preferably configured to position firsttray 20 on an upper plane, or upper tier, relative to second tray 30,which is positioned as a lower tier. Accordingly, second tray 30 ispositioned and configured to move relative to first tray 20 such thatfirst tray 20 is above second tray 30 as second tray 30 is broughtproximate to first tray 20. Second tray 30 thereby can essentially dockbeside and below, or beneath, first tray 20.

Linking member 50 preferably attaches or couples to first tray 20 andsecond tray 30 in a removable fashion, so as to facilitate break downand ease the process of sterilization of the trays and linking member 50between surgical procedures. As depicted in the figures, such removablecoupling is accomplished by use of various clamps or connectors.However, some embodiments may have linking member 50 permanently orsemi-permanently attach to first tray 20 and second tray 30. Suchpermanent or semi-permanent attachment can be affected by any known orlater devised method of attachment, such as adhesives, mechanicalfasteners, or molding/embedding during the manufacture of the traysand/or linking member 50.

Turning to FIG. 3, one possible implementation of linking member 50further consists of a swing-arm bracket 501 configured to couple to thework surface 41 of first tray 20. Swing-arm bracket 501 consists of acoupling member 503 configured to engage a portion of first tray 20sidewall 201 and work surface 41. Coupling member 503 further includes asleeve 504. Linking member 50 further includes a first arm member 505comprising a pin 506 disposed on a proximal end 507 whereby the pinconfigures to slideably engage sleeve 504 and whereby the pin enablesthe sleeve to rotate. First arm member 505 further comprises a distalend 508 having a first-hinge end 509.

Linking member 50 further includes a second arm member 510 comprising acooperating second-hinge end 512 configured to hingeably engagefirst-hinge end 509 and disposed on a proximal end 511 of second armmember 510. Second arm member 510 further includes a distal end 513having a post 515.

While linking member 50 and its constituent components are depicted inthe example embodiment as an articulated arm with one center pivotpoint, this is in no way intended to be limiting. Linking member 50 canbe implemented using any design that facilitates second tray 30 to movewith respect to first tray 20, thereby allowing second tray 30 to bemoved into or away from the surgical field. For example, some suchimplementations may have a single member which pivotably attaches on aproximal end to first tray 20 and a distal end to second tray 30, withno intermediate pivot point. Other examples may include a linking member50 with multiple pivot points, or likewise configured with anaccordion-style folding mechanism, thereby allowing second tray 30 totelescope away from first tray 20, in addition to or in the alternativeto pivoting.

Linking member 50 and its various components are preferably constructedfrom a durable material such as metal or plastic that can be readily andeasily sterilized, and which is robust enough to withstand multiplesterilization process cycles. Alternatively, linking member 50 can beconstructed from any other similarly suitable material or combination ofmaterials now known or later developed.

In this way, system 10, having second tray 30, uses linking member 50 toposition first tray 20 and second tray 30 relative to each other. Secondtray 30 is configured to receive distal end 513 of linking member 50.Accordingly, second tray 30 includes a post-receiving hole 32 configuredto rotatably receive post 515 of second arm member 510. This allowssecond tray 30 to be moved from a first position to a second position,relative to the location of first tray 20.

Optionally, any additional plurality of trays can be provided, and eachincludes any combination of features, alone, or combined as describedwith respect to first tray 20 and second tray 30, above. Or, additionaltrays can include features not discussed herein wherein those featureswould be well understood by those skilled in the art at the time of thisinvention. Linking member 50 may be reconfigured to accommodate one ormore additional trays, in addition to second tray 30. Alternatively, oradditionally, one or more additional trays could be mounted separatelyto first tray 20, either directly or via additional linking members 50.

System 10 further may include in some embodiments at least onespecialized surgical drape 400. Surgical drape 400 has at least onepredefined area 410 printed or otherwise demarked thereon. Surgicaldrape 400 is configured to cover a back table in the operating room. Theat least one predefined area 410 cooperates with a method of arrangingsupplies or instruments thereon. Thus, drape 400 enables and indicatesthe systematic placement of at least one surgical instrument or supply,and also facilitates pre- and post-operative audit counts.

Referring now to FIG. 4, a pre-printed back table surgical drape 400with pre-demarked areas 410 to 440 is depicted. According to oneembodiment of the present invention, surgical drape 400 is opened usingsterile technique and placed on the back table ready to receive anynumber of trays of the present invention along with other surgicalmaterials. These items are placed in the specified locations denoted bythe appropriate areas 410 to 440 on the back-table surgical drape 400according to the requirements for the specific surgical procedure. Exactplacement may be further defined in unique procedure manuals. Surgicaldrape 400 is manufactured using conventional techniques and materialsknown in the art for the manufacture of surgical drapes to be used oninstrument stands.

While surgical drape 400 is depicted in FIG. 4 as possessing four areas410 to 440, this is not intended nor, should it be taken to be limiting;surgical drape 400 may have fewer or greater numbers of pre-demarkedareas, to accommodate a variety of surgical procedures. Furthermore, thepre-demarked areas of surgical drape 400 could be customized to specificsurgical procedures, wherein surgical drape 400 would be specificallyconfigured for one or a few procedures, and thus possess only thosespecific pre-demarked areas that are pertinent to the procedures forwhich surgical drape 400 is tailored.

The instruments used intra-operatively, also called “sharps” in therelevant art, are each individually placed in second tray 30 by thesurgical technician or scrub nurse into a unique designated position.Second tray 30, when needed for use, is moved from the first, retractedposition, to a second, extended position. The second, extended positionis within the sterile field. Second tray 30 swings or otherwise isangled to and presented to the sterile field and is used to deliver orreceive sharps. When this specific action is completed, second tray 30is returned to the first, retracted position below the surgical stand.This process may be repeated several times during a single procedure. Atthe end of a surgical procedure, the sharps instruments contained insecond tray 30 are counted and removed and placed in approved sharpscontainers and disposed of per hospital protocol.

Second tray 30 of system 10 is placed on back-table drape 400 in apre-designated standardized location as set forth on the mappedback-table drape 400. Instruments delivered to the operating room arethen counted and accounted for per protocol.

In another preferred embodiment, system 10 can be adapted for organizinga plurality of medical instruments 12 and a plurality of surgicalsupplies in a sterile operating room in preparation for a procedure,operation, or surgery. In this embodiment system 10 includes a firsttray 20, a second tray 30, an optional third tray 60 (seen in FIG. 10),and a linking member 50 adapted to couple to the first tray 20 to anyadditional tray. One contemplated variation or embodiment of third tray60 is designed specifically to contain any extra instruments that may beneeded during a particular surgical procedure. Typically, this thirdtray 60 is used to introduce instruments or supplies coming from theback table and being placed into the sterile field. Third tray 60 ispreferably equipped with a flat space 62 to allow including surgicaland/or medical supplies that do not need to or otherwise fit into arecess designed to accept medical instruments 12. Third tray canoptionally include at least one slotted recesses 64 that arepre-designated for specific, individual items, supplies, or instruments.This enables quick view counts and safe, easy access for relayinginstruments during surgical procedures.

The present invention contemplates a system of specialized trays adaptedfor specific, predetermined surgical procedures. These trays sharecommon traits, characteristics, and elements as just described above,but are further customized to hold specific instruments based on theintended use during a given procedure. Some examples of thesespecialized trays are now described, below.

General Surgery Services:

Adapted for use with general surgery services, the present inventionincludes a system comprising a plurality of devices. Example trays aredepicted in FIGS. 6A to 10. These devices include:

A universal major tray, similar to first tray 20 depicted in FIGS. 1 and2, and shown in FIG. 8 as tray 800, having features that prevent sharpinjuries as described above. Tray 800 is further configured to arrange aminimum number of instruments necessary for specific procedures. Itreadily couples to a standardized Mayo stand 15 by a recessed guideunderneath the tray and works in conjunction with a second tray 30 in atwo-tier configuration. Further, it accepts a third tray 60 with arecessed sharps-slot feature. This configuration minimizes scrub nurseset up time and provides an easy view for a continuous running count ofinstruments and retractors. Further, this major tray 800 includes arecession and individual slots to accept a standardized number ofinstruments and retractors and orient them in the ready position foreasy relaying to the surgical field.

System 10 may further include a minor tray, presented in detail in FIG.7 which depicts second tray 30 as described above. Second tray 30 alsoincludes the afore-described sharps prevention configuration, as well ascontaining the minimum number of instruments necessary for specificprocedures. Second tray 30 adapts to a standardized minor surgery Mayostand 15 by the recessed guide underneath the tray. It works in atwo-tier arrangement using linking member 50, as a lower tier tray, andpreferably further includes the sharps-slot feature.

In a similar manner, specialized trays having features to orient thesurgical instruments in a “ready” position, and further configured tohold only the specific supplies, retractors, and instruments associatedwith the respective specialized surgical procedure are contemplated.Some contemplated tray systems include, but are not limited to, a CommonBile Duct Tray, a Laparoscopy tray, a Laparoscopic Cholecystectomy Tray,a General Surgery Closing Tray, an Orthopedic Services System includinga Major Ortho Tray and a Minor Ortho Tray, an Open Shoulder Tray, anArthroscopy Tray, a Podiatry Services system including a Podiatry Tray,an Ob/Gyn Services System including the Laparoscopy Tray, an Abdominalhysterectomy Tray, a Vaginal Hysterectomy Tray, a LaparoscopicHysterectomy Tray, a Dilation and Curettage Tray, and a CaesareanSection Tray.

Other specialized tray systems include a Vascular Services systemincluding a Major Vascular Tray, a Minor Vascular Tray, and a VeinAblation Tray. Yet others include a Urology system including an OpenProstatectomy Tray, An Ear Nose and Throat system including aMyringotomy Tray, a Nasal Septoplasty Tray, a Tracheostomy Tray, aStapedectomy Tray, a Major Plastics Tray, and a Minor Plastics Tray.

Each of these aforementioned trays share similar characteristicsincluding materials, construction, the ability to be re-sterilized,having sharp-safe features, and including individual slots forpre-determined instruments. Thus, each of the aforementioned trays isuseable as a first tray 20 and/or second tray 30 with system 10, andmethod 100. FIGS. 6A through 6D depict some common elements theaforementioned trays may possess. However, it will be appreciated bypersons skilled in the relevant art that the general configurations ofthe aforementioned trays with respect to flat areas and recessedcompartments, as well as the size and configuration of the recessedcompartments, can and will vary depending upon the unique needs of anygiven surgical procedure. These variations are contemplated and do notdepart from the disclosed invention.

The trays work with system 10 and method 100 disclosed herein, includingembodiments of method 100 for inventorying instruments both pre-, intra-and post-operatively, for example. The associated FIGS. 6A to 10illustrate some of these contemplated specialized trays made inaccordance with the spirit, scope, and principles of the presentinvention as described herein.

FIGS. 6A through 6D depict a variation of first tray 20, with a broaderwork surface 41 for accommodating more surgical materials other thansharps. Specifically, FIGS. 6A through 6D provide detailed views of thegeometries and features of the tray. It should be appreciated that thesefeatures are generally common to all trays that are useable with system10; however, other trays that include fewer of the features depicted inFIGS. 6A through 6D may equally be usable with system 10.

FIG. 9 depicts a tray 900 that includes a recessed compartment 910,similar in configuration and features to the recessed compartment 21, aswell as a flat work area 920, which is suited for surgical procedureswhere materials that do not fit into a sharps-configured recessedcompartment 910 can be placed. Examples of such materials may includebandages, suture material, staples/staplers, adhesives, medical devices,or any other similar materials that are known to be needed in varioussurgical procedures.

FIG. 10 depicts yet another possible tray configuration, third tray 60,which can be used for extras or auxiliary materials in general surgicalprocedures. Similar to FIG. 9, third tray 60 includes a work area 62 forauxiliary materials in addition to at least one recessed compartment 64.

FIG. 13, finally, depicts still another possible tray configuration,modular tray 1300. Modular tray 1300 is comprised of a first quadrant1302, second quadrant 1304, third quadrant 1306 and fourth quadrant1308. Each of the four quadrants is designed to interlock with the otherquadrants so that modular tray 1300 can be configured and reconfiguredinto different layouts to accommodate the specialized needs of a varietyof different surgical procedures. The quadrants interlock using anyinterlocking mechanism that is known or later developed in the relevantarts that allows modular tray 1300 to be securely assembled and iscapable of withstanding sterilization. Moreover, it should be understoodthat although four quadrants are depicted, this is not in any wayintended to be limiting. Fewer or more sections could be implemented tocreate modular tray 1300 without departing from the disclosed tray.

These specific examples, however, should not be viewed as limiting.Further, features on one specific tray should be understood to beincluded on other trays, even if those specific features are not shownin the drawing. Further still, features, elements, and components can becombined in any combination.

Method

The present invention further contemplates a method 100 using the systemand devices described above. The method enables efficient, reliable,repeatable, and accurate set-up, use, and cleanup of a surgery repletewith all necessary instruments and supplies. Method 100 as depicted inFIG. 11 describes the general flow of preoperative preparation,delivery, surgery, and postoperative procedures involved with the use ofsystem 10, including steps for organizing a plurality of surgicalinstruments and a plurality of surgical supplies in a sterile operatingroom in preparation for a procedure, operation, or surgery.

With reference to FIG. 11, method 100 begins by providing and assemblingvarious components of system 10 described above in step 101. Step 101includes providing a tray system and associated components such as theswing-arm described above, a back-table drape with mapping as describedabove, and a sharps container system. Previously cleaned medicalinstruments 12 necessary for various surgical procedures are placed intospecific slotted mapped locations in a first tray 20 and, in someinstances, a second tray 30. As with medical instruments 12, the traysalso are previously cleaned, although some embodiments may cleaninstruments 12 in place in a tray, as a single unit. The variouscomponents of system 10 are then assembled as recommended by establishedprocedures and manufacturer's recommendations.

In step 102, the component instruments of assembled system 10 arecounted, the count is recorded on a count sheet, and verified againstthe count sheet as well as the various mapped slots for the componentinstruments. A first tray 20 and second tray 30 as part of system 10 maybe designated as upper tier tray and lower tier tray, respectively.

The designated trays with their slotted instruments, the count sheet,and other components of system 10 are placed into one or more containersfor sterilization in step 103. In the preferred embodiment, a singlecontainer containing all components of system 10 is sterilized. However,in some embodiments, medical instruments 12 as well as the tray couldeach be sterilized separately, following which medical instruments 12are placed into the tray while still in a sterilized area, and sealedfor storage and subsequent delivery to the operating theater prior to aprocedure. As discussed above, each tray may be implemented with avariety of different layouts of recesses to accommodate the varied typesmedical instruments 12 that would be useable with various procedures.Thus, a variety of trays and associated instruments 12 may be providedand kept ready for corresponding medical procedures.

Following insertion into the container(s), the container(s) aresterilized in step 104 with the enclosed system 10 per the policies andrequirements of the sterilizing facility. Any appropriate method ofsterilization may be utilized. Once sterilized, system 10 can be storeduntil needed. Once needed for its intended procedure, the sterilecontainer(s) with system 10 are delivered to the operating room in step105.

Medical instruments 12 in place in their various trays are delivered ascomplete and sterilized units to operating rooms. Where a surgicalprocedure may not use all instruments in a given tray, all slots shouldnevertheless be filled; during the surgical procedure, those tools thatare unused are simply left in their given tray.

At the start of a given medical procedure, in step 106, the operatingroom staff verifies that the integrity and sterility of the container(s)and contained system 10 complies with facility policy, and proceeds withsetting up the operating room with system 10. The components of system10 are opened on the clean surface in a sterile fashion and setup usingapproved sterile technique. The various trays, including first tray 20and second tray 30, are opened and dispersed upon suitable stands withinthe designated sterile area using national operating room standards ofsterile technique. Preferably, all positions for medical instruments 12in first tray 20 are filled, which makes visual inspection during pre-and post-operative counts for verification of the presence of allmedical instruments 12 easy. A pre-marked surgical drape 400 can beplaced on a designated back table, and trays 20, 30 may be initiallyplaced upon drape 400 in the appropriate pre-marked areas (e.g. areas410 to 440). The mayo stand(s) to be used is/are draped using steriletechnique. All operating room materials pertinent to the surgicalprocedure are placed on a clean surface.

Once system 10 is deployed from its container(s), in step 107 tray 20and tray 30 are prepared to the mayo stand 15 and back table. Thedesignated upper tier tray is placed upon the mayo stand 15. First tray20 is thus removed from surgical drape 400 and placed upon mayo stand15. One or more medical instruments 12 are already situated and securedin a ready position within the upper tier tray to be relayed to theperson performing the operation with no further manipulation of theinstruments. Once so positioned, the upper tier tray is coupled to alower tier tray, by using a swing-arm bracket, an embodiment of linkingmember 50. Instruments immediately needed for the procedures are placedinto the designated lower tier tray, to be used for passing instrumentsand materials into the sterile operating field.

Any remaining countable items, such as sponges, needles, sutures, etc.,are prepared in step 108, typically to the mapped back-table drape 400.The sharps container system for system 10 is also placed onto theback-table drape 400, and those countable items that are sharps areplaced into the container system in pre-designated locations. Also, instep 108 other necessities such as one or more basins such as disposablebasins and/or large basins for temporary use are placed into eithermapped areas on drape 400 or appropriate stands, as determined byprocedure protocols.

For purposes of implementing and using system 10, first tray 20 may bedesignated the upper tier tray to be used linking member 50, to a secondtray 30. It should be appreciated by the reader that the designation ofa particular tray as first tray 20, and correspondingly as the uppertier tray, where there are a plurality of trays in the operating theateris essentially determined by the nature of any particular surgicalprocedure. In the course of a sufficiently complex operation, it ispossible that multiple trays may in turn, in an iterative fashion, bedesignated first trays.

In the final pre-operative step, the initial count is performed,recorded and verified in step 109. Per national operating roomprocedural standards, prior to commencement of a surgical procedure andprior to the “time out”, all countable surgical instruments andmaterials to be used during a surgical procedure are to be countedverbally and visually by the scrub nurse and circulating nurse. Byseeing that all positions for medical instruments 12 are filled in anygiven tray, the nurse or tech charged with the count has an immediatevisual signal whether any particular tool is missing. Medicalinstruments 12 are thus situated in a ready position to be relayed in astandardized method from their respective, predetermined locations.

Following completion of step 109, system 10 is ready for procedurecommencement.

In step 110, any needed sharps such as needles, syringes, knife blades,etc., are placed onto appropriate positions on the lower tier tray,along with all surgical instruments to be relayed to the surgeonintra-operatively from the respective first tray 20 or second tray 30upon the surgeon's request, with positions between first tray 20 andsecond tray 30 shifting with respect to each other asmaterials/instruments 12 are needed. Materials/instruments 12 are passedto/from the sterile field by extending/retracting the lower tier tray instep 111. The lower tier tray can be placed outside a sterile field bymoving the lower tier away from the upper tier tray by use of linkingmember 50.

In sterile fashion (that is to say that an item has been sterilized by asterile processing department or rendered sterile by the manufacturerand presented or delivered to the operating room as sterilized and readyfor sterile operations and/or procedures), second tray 30 (andsubsequent trays, if present) can be removed from back drape 400 andexchanged for first tray 20 on the mayo stand.

Once the surgeon completes use of a sharps instrument, the instrumentmay be placed on the lower tier tray in a pre-designated slot. Theentire lower tier tray with the used instrument is then returned to thescrub nurse, facilitated by linking member 50. At any time,intra-operatively the lower tier tray, which is attached to the uppertier tray on the Mayo stand 15, may be easily retracted back below theMayo stand 15 to its pre-designated position, away from the sterileoperating field, thus preventing sharps exposure and injuries.

Any non-sharp instruments relayed to the surgeon are placed in thesterile field where the scrub nurse will pick up the instrument andreturn the instrument to the pre-designated instrument slot on itscorresponding tray.

In step 112, inter-operative and post-operative counts are conducted andverified. Accountable items may be counted at any time during thesurgical procedure at the request of any person involved in the surgicalprocedure. Closing counts are performed per protocol of all accountableinstruments, sharps, sponges and other disposable items not included inthis system. Thus, the medical provider involved with the surgery can benotified immediately of any discrepancies and take corrective action perhospital protocol. At the close of procedure, all items are counted bythe scrub nurse and the circulating nurse to make certain all items areaccounted for and placed in their pre-designated position. This is theClosing Count Procedure. The number of counts of surgical items andmaterials varies per surgical procedure (i.e. Uterine Count, MajorAbdominal Vascular Count, Open Heart Count), as would be well understoodin the art.

Upon announcement of closure of the surgical procedure, in step 113 allinstruments are returned to their mapped positions on first tray 20,second tray 30, and any additional tray as appropriate. Sharps andsurgical materials, and any additional items brought to the field duringthe operation, are placed on the drape 400 and sharps container asappropriate. This step may be conducted prior to the closing countprocedure, to facilitate a quick visual inspection and verification ofthe count of all instruments and materials.

Following the final count, system 10 is disassembled, used non-useablematerials are disposed of in an appropriate fashion, and allinstruments, trays, and associated reusable equipment is sent forcleaning and resterilization in step 114. The upper tier tray, swing-armand lower tier tray are removed from the mayo stand and placed into theprevious sterile container to be sent to the sterile processingdepartment for reprocessing per hospital policy, along with medicalinstruments 12, any additional trays, and any other reusable equipment.The sharps container is closed to contain the used sharps and disposedof in a hospital designated biohazard sharps container. Back-table drape400 and other disposable items are discarded into designated biohazardreceptacles per hospital policy.

It will be understood that method 100, while being performed insubstance as described above, may have minor variations that aredependent upon the specific procedure being conducted.

An example of one possible container system 1200 is depicted in FIG. 12,although any suitable container system designed to contain sharps asestablished in the medical arts may be utilized. Container system 1200organizes and contains suture packages in clear view for use duringsurgical procedures. Container system 1200 further includes one or moreslots 1202 that are shaped and designated to hold various sharps such asneedles, blades, sutures, etc. Thus, container system 1200 helpsfacilitate an accurate count of both used and unused needles at alltimes, which further decreases potential confusion of suture countingduring a surgical procedure.

The disclosure above encompasses multiple distinct inventions withindependent utility. While each of these inventions has been disclosedin a particular form, the specific embodiments disclosed and illustratedabove are not to be considered in a limiting sense as numerousvariations are possible. The subject matter of the inventions includesall novel and non-obvious combinations and subcombinations of thevarious elements, features, functions and/or properties disclosed aboveand inherent to those skilled in the art pertaining to such inventions.Where the disclosure or subsequently filed claims recite “a” element, “afirst” element, or any such equivalent term, the disclosure or claimsshould be understood to incorporate one or more such elements, neitherrequiring nor excluding two or more such elements.

Applicant(s) reserves the right to submit claims directed tocombinations and subcombinations of the disclosed inventions that arebelieved to be novel and non-obvious. Inventions embodied in othercombinations and subcombinations of features, functions, elements and/orproperties may be claimed through amendment of those claims orpresentation of new claims in the present application or in a relatedapplication. Such amended or new claims, whether they are directed tothe same invention or a different invention and whether they aredifferent, broader, narrower or equal in scope to the original claims,are to be considered within the subject matter of the inventionsdescribed herein.

The invention claimed is:
 1. A method for organizing a plurality ofsurgical instruments and a plurality of surgical supplies in a sterileoperating room in preparation for a procedure, operation, or surgery,the method comprising: providing a system for organizing a plurality ofsurgical instruments and a plurality of surgical supplies in a sterileoperating room in preparation for a procedure, operation or surgery, thesystem comprising: a first tray for holding at least one medicalinstrument having a handle end and a working sharps-end, the first traycomprising: at least one substantially flat work surface disposed in areference plane; an edge feature surrounding the at least onesubstantially flat work surface, the edge feature having a top surfacestanding proud at a predetermined first positive offset distance fromthe reference plane, the edge feature comprising at least awork-surface-side wall intersecting the at least one substantially flatwork surface at an angle, wherein the top surface disposes generallyparallel to the reference plane and is further defining the firstpositive offset distance from the reference plane; at least one recessedcompartment comprising a bottom surface disposed substantially parallelto the reference plane and offset therefrom at a first negative offsetdistance from the reference plane to accommodate medical instruments; afirst support truss disposed substantially intermediate to the referenceplane and the bottom surface, the first support truss comprising atleast one tool-support notch and a cooperating and corresponding secondsupport truss comprising at least one support groove disposed at asecond negative offset distance from the reference plane; a second tray;a coupling member adapted to couple to the first tray at a firstproximal end of a linking support member and selectively attach to thesecond tray at a second distal end of the linking support member wherebythe linking support member is further configured to enable the secondtray to rotate into and out of a field of sterilization and furtherconfigured to rotatably move from a first position over the first tray,the coupling member further including a sleeve, a first arm membercomprising a pin disposed on a proximal end, the pin configured toslidably engage the sleeve and whereby the pin rotates in the sleeve,the first arm member further comprising a distal end having afirst-hinge end; and a second arm member comprising a cooperatingsecond-hinge end configured to hingeably engage the first-hinge end anddisposed on a proximal end of the second arm member.
 2. The method ofclaim 1 further comprising: placing at least one instrument into aspecific location in the first tray; conducting a pre-operativeaccounting of instruments by visually inspecting the tray and observingthat there is a corresponding instrument in each specific location; andrecording the results of the pre-operative accounting.
 3. The method ofclaim 1, further comprising: providing a plurality of trays, theplurality of trays including a first tray according to claim 1, and asecond tray also according to claim 1; placing the first tray on a Mayostand; placing the second tray outside a sterile field by rotating theswing-arm bracket away from the first tray; placing the first tray andMayo stand in the sterile field; and placing the second tray on aspecifically designated location on a back table, the back table beingcovered by a drape having at least one specific location demarkedthereon.
 4. The method of claim 1, further comprising: conducting apost-operative accounting and placing counted instruments in acontamination-container and transferring the container to the sterileprocessing department; sterilizing one or more instruments; andsterilizing at least one tray.
 5. A method for organizing a plurality ofsurgical instruments and a plurality of surgical supplies in a sterileoperating room in preparation for a procedure, operation, or surgery,the method comprising: providing a system for organizing a plurality ofsurgical instruments and a plurality of surgical supplies in a sterileoperating room in preparation for a procedure, operation or surgery, thesystem comprising: a first tray for holding at least one medicalinstrument having a handle end and a working end, the first traycomprising: at least one substantially flat work surface disposed in afirst reference plane; an edge feature surrounding the at least onesubstantially flat work surface, the edge feature having a top surfacestanding proud at a predetermined first positive offset distance fromthe first reference plane, the edge feature comprising at least awork-surface-side wall intersecting the at least one substantially flatwork surface at an angle, wherein the top surface disposes generallyparallel to the first reference plane and is further defining the firstpositive offset distance from the first reference plane; at least onerecessed compartment comprising a bottom surface disposed substantiallyparallel to the first reference plane and offset therefrom at a firstnegative offset distance to accommodate medical instruments; a secondtray; a swing-arm bracket configured to engage the work surface of thefirst tray, the swing-arm bracket comprising: a coupling memberconfigured to engage a portion of the work-surface-side wall and worksurface of the first tray, the coupling member further including asleeve; a first arm member comprising a pin disposed on a proximal end,the pin configured to slidably engage the sleeve and whereby the pinrotates in the sleeve, the first arm member further comprising a distalend having a first-hinge end; a second arm member comprising acooperating second-hinge end configured to hingeably engage thefirst-hinge end and disposed on a proximal end of the second arm member,a distal end of the second arm member includes a post; the second traycomprising a post-receiving hole configured to rotatably receive thepost of the second arm member, the second tray configured to besupported by the second arm member in at least one position offset fromthe first tray; the second tray further comprising at least one worksurface defining a second reference plane, at least one recessedcompartment offset at a negative distance from the second referenceplane configured to selectively hold at least one surgical instrument ina position whereby the working end is below the given reference plan;placing the first tray on a Mayo stand; placing the second tray outsidea sterile field by rotating the swing-arm bracket away from the firsttray; placing the first tray and Mayo stand in the sterile field; andplacing the second tray on a specifically designated location on a backtable, the back table being covered by a drape having at least onespecific location demarked thereon.
 6. A method for organizing aplurality of surgical instruments and a plurality of surgical suppliesin a sterile operating room in preparation for a procedure, operation,or surgery, the method comprising: providing a system for organizing aplurality of surgical instruments and a plurality of surgical suppliesin a sterile operating room in preparation for a procedure, operation orsurgery, the system comprising: a first tray for holding at least onemedical instrument having a handle end and a working end, the first traycomprising: at least one substantially flat work surface disposed in areference plane; an edge feature surrounding the at least onesubstantially flat work surface, the edge feature having a top surfacestanding proud at a predetermined first positive offset distance fromthe reference plane, the edge feature comprising at least awork-surface-side wall intersecting the at least one substantially flatwork surface at an angle, wherein the top surface disposes generallyparallel to the reference plane and is further defining the firstpositive offset distance from the reference plane; at least one recessedcompartment comprising a bottom surface disposed substantially parallelto the reference plane and offset therefrom at a first negative offsetdistance from the reference plane to accommodate medical instruments;support truss disposed substantially intermediate to the reference planeand the bottom surface, the support truss comprising at least onetool-support notch; a second tray coupled to the first tray by aswing-arm; placing at least one instrument into a specific location inthe first tray; conducting a pre-operative accounting of instruments byvisually inspecting the tray and observing that there is a correspondinginstrument in each specific location; and recording the results of thepre-operative accounting.
 7. The method of claim 6, wherein theswing-arm further comprises: a linking support member adapted to coupleto the first tray at a first proximal end of the linking support memberand selectively attach to the second tray at a second distal end of thelinking support member whereby the linking support member is furtherconfigured to enable the second tray to rotate into and out of a fieldof sterilization; and the linking support member further comprising ahinge disposed between the distal and proximal ends.
 8. The method ofclaim 6, wherein the first tray of the provided system further comprisesin conjunction with the first support truss: a cooperating andcorresponding second support truss comprising at least one supportgroove disposed at a negative offset distance from the reference plane.9. The method of claim 6, further comprising: conducting apost-operative accounting and placing counted instruments in acontamination-container and transferring the container to the sterileprocessing department; sterilizing one or more instruments; andsterilizing at least one tray.